In the animal health industry the need to treat up to 500 animals with a single dosage preparation is a common requirement. For practical purposes, therefore, a high dosage package would be beneficial. A high dosage package consists of two parts, the formulated powder and saline solution, which are combined to produce a high dosage preparation. The ADD-Vantage.RTM. packaging system, developed by Abbott Laboratories, is an example to be used for such high dosage formulations. The package consists of a small vial carrying the lyophilized powder and a nonbreakable plastic bag filled with saline. When both components are combined the injectionible preparation is complete.
The preparation of vials containing formulated powder is achieved by lyophilizing solutions of a biologically active drug, including proteins, peptides and polypeptides, in a vial. For economic reasons, it is important to maximize quantities of formulated powder in each vial which makes it necessary to work with high drug concentrations and high fill volumes. High fill volumes and high drug concentrations, however, have been shown to produce excessive vial breakage during the lyophilization process.
It is an object of this invention to provide a composition containing a biologically active drug and a method for the preparation of formulated powder by lyophilizing highly concentrated solutions in highly filled vials without breakage.
A further object of this invention is to provide a package system consisting of the vials containing formulated powder and a container filled with formulated saline solutions which, upon reconstitution, will produce a solution of proper concentration required, for example, in injectible dosage forms.